Condition category
Cancer
Date applied
09/10/2007
Date assigned
14/01/2008
Last edited
01/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Riyaz Shah

ORCID ID

Contact details

Kent Oncology Centre
Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NSCLC-DOCET_L_02602

Study information

Scientific title

Acronym

ELTAX

Study hypothesis

To assess the efficacy of docetaxel (60 mg/m^2, on day one of every 21-day cycle [d1, q21]) as first line chemotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC).

Ethics approval

In progress through NRES, pending as of 14/01/2008.

Study design

Simon 2 stage MiniMax: this is a single arm (non-randomised) phase II trial with 2 stages

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Advanced stage non small cell lung cancer

Intervention

This is a single arm (non-randomised) phase II trial with 2 stages. The first stage will involve recruiting 31 patients. If there is evidence of activity then the trial will complete recruitment of a further 24 patients.

Patients will be treated with docetaxel 60 mg/m^2 intravenously (iv) once every 3 weeks for 4 - 6 cycles. Patients will be followed up until death.

Please note that as of 01/08/2012 this record was updated to show that the trial was stopped in 2009.

Intervention type

Drug

Phase

Phase II

Drug names

Docetaxel

Primary outcome measures

Response rate, measured by RECIST criteria once all patients have completed protocol defined therapy.

Secondary outcome measures

1. Progression free survival, measured using the Kaplin Meier method
2. Overall survival, measured using the Kaplin Meier method
3. Survival in patients who received less than or equal to 2, greater than 2 but no more than 4 versus more than four 4 cycles of chemotherapy, measured using the Kaplin Meier method
4. Toxicity
5. Quality of life, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ-C30 and QLQ-LC13). Scoring will be performed using the EORTC QLQ-C30 scoring manual
6. Comparison of the use of second and third line therapies

Overall trial start date

01/01/2008

Overall trial end date

01/01/2009

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

1. Aged greater than or equal to 70 on the day of first treatment
2. Histologically or cytologically confirmed NSCLC
3. Any stage not suitable for surgery or radical radiotherapy
4. Radiologically evaluable disease (by Response Evaluation Criteria In Solid Tumours [RECIST] criteria) of at least one measurable lesion on chest X-ray (CXR) or computed tomography (CT)
5. Performance status World Health Organization (WHO) of 0, 1 or 2
6. Life expectancy greater than 12 weeks
7. Adequate haematological and biochemical function

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

55

Participant exclusion criteria

1. Prior chemotherapy (previous surgery and palliative radiotherapy are allowed)
2. Uncontrolled non-cancer systemic disease
3. Significant clinical or laboratory abnormalities
4. Concomitant or previous malignancy likely to interfere with treatment outcome
5. WHO performance status of worse than 2
6. Inadequate renal function
7. Inadequate bone marrow function

Recruitment start date

01/01/2008

Recruitment end date

01/01/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kent Oncology Centre
Maidstone
ME16 9QQ
United Kingdom

Sponsor information

Organisation

Maidstone and Tunbridge Wells NHS Trust (UK)

Sponsor details

Research Management and Governance Centre
Kent and Medway Primary Care Trust
Ward Block
Preston Hall
Aylesford
Kent
Maidstone
ME20 7NJ
United Kingdom

Sponsor type

Government

Website

http://www.kentandmedway.nhs.uk/

Funders

Funder type

Industry

Funder name

Sanofi-Aventis Pharma (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes